Use our guide to learn which trials are right for you!

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known whether chemotherapy is effective in
treating women who have undergone surgery and radiation therapy for relapsed breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy
in treating women who have undergone resection for local and/or regional relapsed breast
cancer.

- Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an
adjuvant chemotherapy regimen as determined by the investigator. Patients also receive
radiotherapy* within 6 months after surgery and after the completion of chemotherapy OR
integrated with chemotherapy.

NOTE: *Patients with clear margins (R0) who received prior adjuvant radiotherapy are not
required to receive further radiotherapy

- Local failure is defined as a tumor recurrence in any soft tissue of the
ipsilateral conserved breast or the chest wall, mastectomy scar, and/or
skin

- Regional failure is defined as a tumor recurrence in the ipsilateral
axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla,
and/or ipsilateral internal mammary. Regional failure does not include
supraclavicular lymph nodes or tumor in the opposite breast

- No other prior recurrence in any site, including local

- Surgical resection of the recurrence meeting 1 of the following criteria:

- Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for
patients who had no prior adjuvant radiotherapy

- Mastectomy of the recurrence with uninvolved ("clear") margins after
lumpectomy/quadrantectomy alone for the primary

- Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are
allowed for patients with HER-2 positive tumors and must be declared prior to
randomization

- No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes,
by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or
bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically
indicated (e.g., bone pain)

- No macroscopically incomplete surgery

- No bilateral malignancy except carcinoma in situ

- No suspicious mass in the opposite breast unless that mass has been proven by biopsy
to be benign

- No skeletal pain of unknown cause

- No hot spots on bone scan for which metastases cannot be ruled out by x-ray,
MRI, and/or CT scan